510(k) Report

FDA applicant

Akern USA, LLC

Greenwood Village, CO1 decision2009–20090 recalls

FDA records 1 decision for Akern USA, LLC (Greenwood Village, CO) in 2009: 1 510(k) clearance. All are in product code MNW (Analyzer, Body Composition). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Akern USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Akern USA, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MNWAnalyzer, Body Composition1decision

What has FDA decided for it lately?

  • K091369ElectrofluidgraphAkern USA, LLC · 2009

The one decision as Akern USA, LLC →